Validation in Pharmaceutical Analysis - Online Training Recording
Lifecycle Concept, ICH Q2(R2) & Training Materials, USP <1225> Revision
Course No. 23032
Speakers
Dr Joachim Ermer
Ermer Quality Consulting
USP <1225> Revision: Useful Complementation, Interpretation & Remediation of ICH Q2(R2)
Target Group
Managers and professionals from Quality Control, Quality Assurance and Regulatory Affairs who want to deepen their understanding of GMP requirements for analytical procedure validation.
Participants looking for practical recommendations for efficient study design, execution and evaluation of analytical Validation.
Objectives
The regulatory requirements to validation of analytical procedures utilised for release and stability studies of drug substances and drug products are described in the ICH guideline Q2(R2). However, its degree of detail is rather low, and the examples provided in Annex 2 often lack orientation beyond the guideline text. Therefore, this Live Online Training provides besides these regulatory expectations practical interpretation and recommendations for demonstration of the suitability of analytical procedures. The revision of the USP General Information Chapter <1225> “Validation of Analytical Procedures”, published November 2025 provides urgently needed interpretation of some neglected aspects in the ICH guideline Q2(R2), for example with respect to precision levels, replication strategy for the reportable result, and acceptance criteria.
The ICH Q2(R2)/Q14 Training Materials published in July 2025 is critically discussed, emphasizing some deficiencies and gaps, for example the inappropriate mixing of precision levels, or the lack of orientation how to derive appropriate acceptance criteria or to establish a suitable replication strategy.
A rational and efficient validation approach is ultimately based on the respective routine application, which should be reflected in the validation design. This includes the identification of the relevant performance parameters, the selection of appropriate tests and calculations and, in particular, the establishment of acceptance criteria for the Evaluation.
These recommendations are illustrated by practical exercises, demonstrations, and interactive polls/discussions (Mentimeter based).
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Fees (per delegate, plus VAT) ECA Members EUR 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,290 EU GMP Inspectorates EUR 645 The fee is payable in advance after receipt of invoice.
Conference language The official conference language is English.
Testimonials
